VITESSE DBV712-306 (DBV Peanut Allergy)
A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of Epicutaneous Immunotherapy with DBV712 250 µg in 4-7-year-old Children with Peanut Allergy
- Sex at Birth: Any
- Age: Child (Birth - 17)
- Accepting Healthy People: No
- Type: Interventional / Therapeutic
- Trial Phase: Phase III
- Conditions Being Studied: Food Allergies
Study Purpose
The main purpose of this study is to learn how well DBV712 works and how safe it is compared with a placebo patch over a 12-month study treatment period in children aged 4 to 7 years with peanut allergy. DBV712 is an investigational drug using a specially-designed patch applied on the skin that contains a dry extract of peanut protein. The small amount of peanut protein (approximately 1/1000 of 1 peanut worth of protein) in the study drug patch is designed to desensitize (or make less sensitive) a peanut-allergic person by repeated exposures to very small amounts of peanut.
Who Can Participate
Age: 4-7
Locations
UH Cleveland Medical Center
11100 Euclid Avenue
Cleveland OH, 44106
- UH IRB: SITE00001953
- StudyID: 2022-01111
- ClinicalTrials.gov: NCT05741476
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